Hollywog Wireless Remote Control Pain Relief for Lower Back User manual

Hollywog

2830 Amnicola Hwy

Chattanooga, TN 37406 USA

+1 423 305 7778

[email protected]

www.hollywog.com

Patents Pending

Patente Pendiente

Brevets en cours d’homologation

Zum Patent angemeldet

User Manual

Manual de Usuario

Manuel d’utilisation

Benutzerhandbuch

What is Hollywog

WiTouch

Congratulations on your purchase of the Hollywog WiTouch device. Hollywog WiTouch is the ﬁrst wireless remote controlled

pain relief device incorporating TENS technology to speciﬁcally target back pain. The thin and ﬂexible design perfectly contours

the back for maximum surface contact. The advanced electronics design maximizes energy use, providing over 150 30-minute

treatment sessions per battery life. This innovative device is safe, drug-free, easy to use, discreet & comfortable to wear, and

most importantly allows you to control your pain to maintain an active lifestyle.

What is TENS?

TENS (Transcutaneous Electrical Nerve Stimulation) is a non-invasive, drug-free method of controlling pain by the transmission of

electrical stimulation to the body’s nerve or muscle ﬁbers through the skin. Pain relief or suppression is achieved by:

 •Suppressingthetransmissionofpaininnerves(GateControlTheory)and

 •Increasingthedischargeofthebody’sendorphins,whichreducesthesensitivitytopaininthecentralnervoussystem

(Opiate Release Theory)

The Hollywog WiTouch’s exclusive and patented waveform incorporates BOTH clinical theories of TENS to provide pain relief.

The Hollywog WiTouch provides a safe, easy to apply, pain management system for self-treatment when needed.

INDICATIONS FOR USE

The Hollywog WiTouch is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to

strain from exercise or normal household and work activities.

CONTRAINDICATION

Do not use this device if you have a cardiac pacemaker, implanted deﬁbrillator, or other implanted metallic or electronic device.

Such use could cause electric shock, burns, electrical interference, or death.

WARNINGS

• Donotusethisdeviceacrossorthroughyourchestbecausetheelectricalcurrentsintroducedintothechestmaycauserhythm

disturbances to your heart, which may be lethal.

• Donotusethisdeviceifyouaresusceptibletorhythmdisturbancestotheheartunlessunderthedirectionofyourphysician.

• Donotusethisdeviceoveryourneckbecausethiscouldcauseseveremusclespasmsresultinginclosureofyourairway,

difﬁculty in breathing, or adverse effects on heart rhythm or blood pressure.

• Consultwithyourphysicianbeforeusingthisdeviceifyouareinthecareofaphysician.

• Consultwithyourphysicianbeforeusingthisdeviceifyouhavehadmedicalorphysicaltreatmentforyourpain.

• Stopusingthisdeviceandconsultyourphysicianifyourpaindoesnotimprove,becomesmorethanmild,orcontinuesformore

than ﬁve days.

• Donotusethisdevicewhiledriving,operatingmachinery,orduringanyactivityinwhichelectricalstimulationcanputyouat

risk of injury.

• Donotusethisdeviceoveropenwoundsorrashes,oroverswollen,red,infected,orinamedareasorskineruptions(e.g.,

phlebitis, thrombophlebitis, varicose veins);

• Donotusethisdeviceover,orinproximityto,cancerouslesions.

• Donotusethisdeviceonchildrenbecauseithasnotbeenevaluatedforpediatricuse.

• Donotusethisdeviceinthepresenceofelectronicmonitoringequipment(e.g.,cardiacmonitors,ECGalarms),whichmaynot

operate properly when the electrical stimulation device is in use.

• Donotusethisdevicewheninthebathorshower.

• Donotusethisdevicewhilesleeping.

• Donotusethisdeviceonabnormalskin,orskinthatisnotintact,clean,orhealthy.

PRECAUTIONS

• DONOTSTARTstimulationofthedevicepriortoapplicationofthedevicetotheback.

• Keepthisdeviceoutofthereachofchildren.

• Thesafetyofnervestimulationhasnotbeenestablishedduringpregnancy;thereforedonotusethisdeviceifyouare

pregnant, or suspect that you are pregnant, unless under the direction of your physician.

• Thisdeviceshouldnotbeappliedonoracrossyourheadsincetheeffectsofstimulationofthebrainareunknown.

• Thisdeviceisforsymptomatictreatmentand,assuch,suppressesthesensationofpainthatwouldotherwiseserveasa

protective mechanism.

• Ifyouhavesuspectedordiagnosedheartdisease,youshouldfollowprecautionsrecommendedbyyourphysician.

• Ifyouhavesuspectedordiagnosedepilepsy,youshouldfollowprecautionsrecommendedbyyourphysician.

• Usethisdevicewithcautionifyouhaveatendencytobleedinternally,suchasfollowinganinjuryorfracture.

• Consultwithyourphysicianpriortousingthisdeviceafterarecentsurgicalprocedure,becausestimulationmaydisruptthe

healing process.

• Donotusethisdeviceforpainofcentralorigin,includingheadache.

• Thisdevicedoesnotprovidecurativevalue.

• Thelong-termeffectsofnervestimulationareunknown.

• Youmayexperienceskinirritationorhypersensitivityduetotheelectricalstimulationoradhesivemedium(gelpads).

• Usethisdevicewithcautionifstimulationisappliedoverthemenstruatingorpregnantuterus.

• Usethisdevicewithcautionifstimulationisappliedoverareasofskinthatlacknormalsensation.

• Usethisdeviceonlywiththegelpadsandaccessoriesrecommendedbythemanufacturer.

•Donotremovethisdevicefromyourskinduringstimulationtreatment.

• Donotplaceyournger,oranyobject,betweenornearyourskinandtheadhesivegelpadswiththestimulationactivated.

• Thisdeviceisnottobeusedinthepresenceofammableoranesthesiagasses.

ADVERSE REACTIONS

• Isolatedcasesofskinirritationorburnsmayoccurduetoelectricalstimulationoradhesivemedium(gelpads).

• Stopusingthedeviceandconsultwithyourphysicianifyouexperienceadversereactionsfromuseofthisdevice.

CONTENTS

• 1HollywogWiTouchdevice

• 1HollywogWiTouchremotecontrol

• 1PackageHollywogWiTouchgelpads(5pair)

• 2AAAalkalinebatteries

• 1CR2032lithiumbattery(installedinremote)

• 1Size#0Phillipsheadscrewdrivertool

• 1StorageBox

• 1UserManual

• 1QuickStartGuide

PREPARE your Hollywog WiTouch

1. Prepare the treatment area by washing and drying the skin thoroughly. Excessive hair should be trimmed (NOT shaved), and

the treatment area should be void of oils and/or lotions. DO NOT apply the main device over broken skin.

2. Remove battery cover from the device with the included screwdriver tool and insert 2 AAA batteries noting correct +/- polarity.

Replace the battery cover.

3. Press and hold the ON/OFF button on the WiTouch device for one (1) second. The LED will begin blinking green once every

 two(2seconds).YourWiTouchdeviceisnowONandreadyforuse.

4. Remove clear battery insulation tab from the remote control to activate battery. Discard clear tab.

5. Remove two (2) WiTouch gel pads from the package and separate the pads at the perforation in the liner.

6. Remove the blue liners from one (1) gel pad by peeling away the folded edges of the liners. Discard the blue liners.

DO NOT remove the green protective liner during this step.

7. Apply the gel pad to one (1) black electrode area on the bottom of the Hollywog WiTouch device. Align the shape of the gel

pad to match the shape of the black electrode area. Firmly press the gel onto the electrode across the entire surface of the gel

pad to ensure good adhesion.

8. Repeat steps 6 - 7 for the second gel pad and electrode area.

9. YourHollywogWiTouchisnowreadyforuse.DONOTactivatestimulationofthedevicepriortoapplicationofthedevice

to the back.

OPERATE your Hollywog WiTouch

1. Remove the green protective liners from both gel pads on the device by slowly peeling the liner from one inside corner towards

the outside corner of the electrode area. DO NOT discard the protective liners as the protective liners will be reapplied to the

gel pads for storage after use. Take care to not touch or allow objects to come in contact with the gel pad as this may interfere

with the adhesion properties of the gel pad.

2. Placethedeviceonyourbackovertheareaofbackpain,aligningthecenterofthedeviceoverthespine.Makesurethegel

 padsmakegoodcontactwiththeskin.DONOTapplythegelpads/electrodesdirectlyoverthespine.Iftheareaofbackpain

 cannotbeaccessed,requestassistancefromanotherpersonforapplication.

3. OntheHollywogWiTouchremotecontrol,presstheSTART/STOPTREATMENTbuttonmomentarily.TheLEDwillblink

green one (1) time. The Hollywog WiTouch electrical stimulation treatment has now started. On the WiTouch device,

the LED will now begin blinking green very rapidly for the duration of the treatment.

4. PresstheINCREASEINTENSITY(+)buttontoincreasethestimulationtoacomfortablelevel.Todecreasethestimulation

 intensityanytimeduringtreatment,presstheDECREASEINTENTISY(-)button.

5. Treatment will automatically stop after 30 minutes. Treatment can be stopped at any time by pressing the START/STOP

 TREATMENTbuttonontheremotecontrol.DONOTremovethedeviceuntiltreatmenthasstopped.

6. CareshouldbetakentonotinadvertentlydepresstheON/OFFbuttononthedevicewhenbeingworn.IftheON/OFFbuttonis

depressed during use, the treatment will stop. To restart treatment, press and hold the ON/OFF button for 1 second, then

initiate the treatment with the remote control. The 30 minute treatment will start over from the beginning.

7. The Hollywog WiTouch device can be left in position without removal for multiple treatments during the day. To initiate

additional treatments, repeat step 3 above when treatment is desired. NOTE:Itisrecommendedtowaitaminimumof30

minutes between treatments.

8. The Hollywog WiTouch device will automatically turn off after two (2) hours of inactivity. To turn on the device, press

and hold the ON/OFF button on the WiTouch device for one (1) second. The LED will begin blinking green once every two (2

 seconds).OntheHollywogWiTouchremotecontrol,presstheSTART/STOPTREATMENTbuttonmomentarily.TheLEDwill

blink green one (1) time. The Hollywog WiTouch electrical stimulation treatment has now started. On the WiTouch

device, the LED will now begin blinking green very rapidly for the duration of the treatment..

STORE your Hollywog WiTouch

1. When you have completed treatments and ready to store the Hollywog WiTouch, you can remove the device from your

back. Slowly peel the WiTouch device away from the skin, grasping the edge of the device and gel pad simultaneously to

ensure gel pad does not come off the device and stay on the skin.

2. Applythegreenprotectivelinerstothegelpads.Makesurethegelpadiscompletelycovered.

3. Press and hold the ON/OFF button on the device for 1 second to turn off the device. The LED will will stop blinking green.

4. Place the Hollywog WiTouch device and remote control in the storage box.

5. IftheHollywogWiTouchisnottobeusedforalongperiodoftime,removethe2AAAbatteriesfromtheHollywog

WiTouch battery compartment to prolong battery life.

6. To turn on the device, press and hold the ON/OFF button on the WiTouch device for one (1) second. The LED will begin

blinking green once every two (2 seconds). On the Hollywog WiTouch remote control, press the START/STOP

 TREATMENTbuttonmomentarily.TheLEDwillblinkgreenone(1)time.TheHollywogWiTouchelectricalstimulation

treatment has now started. On the WiTouch device, the LED will now begin blinking green very rapidly for the duration of

the treatment.

REPLACE Hollywog WiTouch Gel Pads

HollywogWiTouchGelPadsaresinglepersonuse.Thegelpadswilllastforapproximately2-5applications.Thenumberof

applications will vary person-to-person depending upon skin type, oils and PH levels. When the gel pads no longer adhere completely,

it is time to replace the gel pads. To purchase replacement gel pads for your WiTouch device contact your original purchase retailer.

1. Slowly peel the gel pad away from the black electrode area of the Hollywog WiTouch device. Be sure to remove all gel

residues from the electrode area.

2. Remove two (2) gel pads from the package and separate the pads at the perforation in the liner.

3. Remove the blue liners from one (1) gel pad by peeling away the folded edges of the liners. Discard the blue liners. DO NOT

remove the green protective liner at this time.

4. Align the shape of one (1) gel pad to match the shape of the black electrode area. Apply the gel pad to the black electrode

area, ﬁrmly pressing the gel onto the electrode. Press across the entire surface of the gel pad to ensure good adhesion.

5. Repeat step 3 and 4 for the second gel pad and electrode area.

6. Follow instructions for operation or storage of your Hollywog WiTouch

MAINTAIN your Hollywog WiTouch

• TheHollywogWiTouchLEDindicatorwillalertwhenbatteriesrequirereplacement:

1. Hollywog WiTouch device:

   •

When pressing ON/OFF button to turn on device: LED indicator blinks yellow every two (2) seconds when the device is ON.

   •

During stimulation treatment: LED indicator will blink yellow rapidly during the treatment.

2. Hollywog WiTouch remote control: LED indicator blinks yellow once when the START/STOP button is pressed.

•ReturntheHollywogWiTouchtoitsstorageboxwhennotinusetoensurethedeviceisprotectedduringstorageand

transport.

•TheHollywogWiTouchshouldbeoperated,transportedandstoredattemperaturesbetween50°Fand104°F(10°C

 and40°C),withrelativehumiditybetween30%-85%.Allvalueshave+/-10%tolerance.

•Consultyourlocalauthoritiesforproperbatterydisposal.

•IftheHollywogWiTouchisnotworkingproperly,stopusingimmediatelyandcontactHollywogCustomerService.

•Donotdisassembleormodifythisdevice.

CLEAN your Hollywog WiTouch

Hollywog WiTouch Electrodes are single person use. Use a damp cloth and mild soap to gently wipe clean. Remove any soap residue

fromcleaning.Damagetothedeviceand/orremotecontrolwilloccurifsubmergedinwaterorotherliquids.WiTouchismanufactured

with water detection technology to detect exposure to water that may cause damage to the electronics and void the product warranty.

TECHNICAL SPECIFICATIONS

Channels: Single channel

Waveform:Asymmetricbiphasicsquarepulse.

Pulse Amplitude: 0 ~110 mA = 0 ~ 55 volts, adjustable (at 500 ohm load)

PulseFrequency:(Hz)5-120

Pulse Width: (μs) 120 - 240

Timer Control: (mins) 30

Power Supply:

 Device:Two(2)AAAbatteries(InternallyPowered)

 RemoteControl:One(1)CR2032Lithiumbattery(InternallyPowered)

Size (D x W x H): 0.7” x 7.5” x 3.5” (18 mm x 191 mm x 90 mm)

Weight (including battery): 4.8 oz (136 g)

SafetyStandards:IEC/EN/UL60601-1,IEC/EN60601-1-2,IEC60601-2-10,CAN/CSAC22.2No.601.1,EN300200/EN301498-3

MadeinUSA

LED Indicator Guide

Event

Low battery - device

Low battery - remote control

Device transition from OFF to ON

Device transition from ON to OFF

Device transition from ON to START

STIMULATION mode

On remote control, press of

START/STOP TREATMENT button to

either START or STOP treatment

Device at maximum intensity and

+/- button pressed on remote or device

Remote control communication error

LED Color

Yellow

Green

None

Green

Yellow

LED Sequence

One (1) blink every two (2)

seconds when the device is ON.

Rapid blinking during the

stimulation treatment.

One (1) blink every time the

START/STOP button is pressed.

One (1) blink every two (2)

seconds.

Green blinking stops.

Rapid blinking during treatment.

One (1) blink when START/STOP

button is pressed.

Two (2) blinks each time button

is pressed.

One (1) rapid blink, followed by

two (2) rapid blinks.

This device complies with part 15 of the

FCC Rules. Operation is subject to the

following two conditions: (1) This device

may not cause harmful interference,

and (2) this device must accept any

interference received, including

interference that may cause undesired

operation.

RF:2.4GHztransceiver

Device:

 FCCID:N8L-HWOGTENS11

 IC:10346A-HWOGTENS11

Remote Control:

 FCCID:N8L-HWOGTENS12

 IC:10346A-HWOGTENS12

0120

European

Conformity

European

Directive

2002/96/EC

85%

30%

Atmospheric

Pressure Limitations

Temperature

Limitations

Humidity Limitations

Limitations of Use and Storage

MDSS GmbH

Schiffgraben 41

30175 Hannover, Germany

European Authorized Representative:

TROUBLESHOOTING

YourHollywogWiTouchdevicecomesfromthefactorypairedwiththeremote.YouDONOThavetopairthedeviceandremote

priortouse.Intherareinstancetheremoteanddevicebecomeunpairedandwirelesscommunicationbetweenthemstop,follow

these steps to pair the units:

1. Remove the two (2) AAA batteries from the device battery compartment

2. On the remote control, press and hold both the + and – buttons for ﬁve (5) seconds. The LED indicator will blink green,

one (1) blink every second.

 3.Insertthetwo(2)AAAbatteriesintothedevicebatterycompartment.

The device and the remote control will pair automatically, and the remote control LED indicator will blink green ﬁve (5) times.

WARRANTY

Hollywog, LLC (“Company”) warrants the Hollywog WiTouch (“Product”) is free of defects in materials and workmanship. This

warrantyshallremainineffectfor1year(12months)fromthedateofpurchase.IftheseProductsfailtofunctionduringthe1year

warranty period due to a defect in material or workmanship, at the Company’s Option, Company or the selling dealer will replace

the respective Product without charge within a period of thirty (30) days from the date on which the Product is returned to the

Company or the dealer.

This Warranty Does Not Cover:

HollywogGelPads

Any defects, damage, loss, malfunction or failure in the Product caused by product misuse, alteration, disassembly or any use

thatisinconsistentwiththeProduct’sInstructionManual.

COMPANY SHALL NOT BE LIABLE IN ANY EVENT FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES.

¿Que es Hollywog

WiTouch

Felicitaciones por su compra del dispositivo Hollywog

WiTouch. El dispositivo Hollywog WiTouch es el primer dispositivo

controladoporremotoinalámbricoparaelaliviodedoloryqueincorporalatecnologíadeTENSparaapuntarespecícamente

el dolor de espalda. El diseño delgado y ﬂexible perfectamente perﬁla la espalda para el contacto superﬁcial máximo. El diseño

electrónicoavanzadoutilizaalmaximizolaenergía,produciendomásde150tratamientosde30minutosporcargadebatería.

Este dispositivo innovador es seguro, sin medicina, fácil de usar, discreto y cómodo para llevar puesto, y más importante, permite

queustedcontrolesudolor,paramantenerunestilodevidaactiva.

¿Qué es TENS?

TENS (Estimulación Trascutánea Eléctrica del Nervio) es un no invasivo, sin medicina de controlar el dolor por la transmisión del

estímuloeléctricoalasbrasdemúsculoonerviodelcuerpoporlapiel.Elaliviodedolorolasupresiónesadquiridapor:

 •Supresióndelatransmisióndedolorennervios(TeoríadeControlGate)y

 •Aumentoeldescargodeendornasdelcuerpo,quereducelasensibilidaddedolorenelsistemanerviosocentral(Teoría

Liberación de Opiatos)

LaformadeondaexclusivaypatentadadeHollywogWiTouchincorporalasDOSteoríasclínicasdeTENSparaproporcionar,alivio

de dolor. El Hollywog WiTouch proporciona un sistema seguro, fácil de aplicar, mantenimiento de dolor para tratamiento personal

cuando necesario.

INDICACIONES PARA USO

HollywogWiTouchestáindicadoparaelaliviotemporaldeldolorasociadoconmúsculosdoloridosenlapartebajadelaespalda

debido a tensiones de ejercicios, actividades caseras o de empleo.

CONTRAINDICACIÓN

Nouseestedispositivosiustedtieneunmarcapasocardíaco,undesbriladorimplantado,uotrodispositivometálicoo

electrónicoimplantado.Talusopodríacausarsacudidaeléctrica,quemaduras,interferenciaeléctrica,omuerte.

ADVERTENCIAS

• Estedispositivonosedebeusaratravésoporsupechoporquelascorrienteseléctricasintroducidasenelpechopueden

 causarperturbacionesderitmoasucorazón,quepuedeserletal.

• Estedispositivonosedebeusarsiustednoessusceptibleaperturbacionesderitmoalcorazónamenosqueestebajola

dirección de su médico.

• Estedispositivonosedebeusarsobresucuelloporqueestepodríacausarespasmosdemúsculoseverosquecausanelcierre

 desuvíaaérea,dicultadenrespiración,oefectosadversosenritmodecorazónotensiónarterial.

• Consultesumédicoantesdeusarestedispositivosiustedestábajoelcuidadodeunmédico.

• Consulteconsumédicoantesdeusarestedispositivosiustedhatenidoeltratamientomédicoofísicoporsudolor.

• Dejedeusarestedispositivoyconsulteasumédicosisudolornomejora,sinosehacemássuave,osiguecondolormásde

 cincodías.

• Estedispositivonosedebeusarmientrasconduce,trabajaconmaquinariadeoperaciones,odurantecualquieractividaden

 queunestímuloeléctricopuedaponerloenpeligro.

• Estedispositivonosedebeusarsobreheridasabiertasoerupciones,osobreáreasaumentadas,rojas,infectadasoinamadas

o erupciones de piel (p.ej, Flebitis, Tromboﬂebitis, venas varicosas);

• Estedispositivonosedebeusar,oenproximidada,lesionescancerosas.

• Estedispositivonosedebeusarenniñosporquenohasidoevaluadoparaelusopediátrico.

• Estedispositivonosedebeusarenlapresenciadelequipodemonitoreselectrónico(p.ej,monitorescardíacos,alarmasde

 ECG),nofuncionancorrectamentemientrasseutilizaeldispositivodeestímuloeléctrico.

Manual de Usuario

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Hollywog Wireless Remote Control Pain Relief for Lower Back, WiTouch User manual

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